NCT02892422

Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia

Interventional, Open-label, Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 528 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.

Detailed description

Safety study in patients with schizophrenia who have participated and completed a study investigating Lu AF35700 including Studies 16159A and 16323A. Or in patients with schizophrenia for whom a switch of antipsychotic treatment can be potentially beneficial according to the investigator's clinical judgement.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Lu AF35700	Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-10-10
• Completion: 2019-10-10
• First posted: 2016-09-08
• Last updated: 2020-10-26
• Results posted: 2020-10-26

Locations

102 sites across 13 countries: United States, Bulgaria, Canada, Czechia, Estonia, Mexico, Poland, Romania, Russia, Serbia, Slovakia, Spain, Ukraine